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Frances Oldham Kelsey, the FDA, and the Battle Against Thalidomide
- Narrado por: Andrea Gallo
- Duración: 16 h y 41 m
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Resumen del Editor
In the early 1960s, Dr. Frances Oldham Kelsey of the U.S. Food and Drug Administration became one of the most celebrated women in America when she prevented a deadly sedative from entering the U.S. market. A Canadian-born pharmacologist and physician, Kelsey saved countless Americans from the devastating side effects of thalidomide, routinely given to pregnant women to prevent morning sickness.
As the FDA medical officer charged with reviewing Merrell Pharmaceutical’s application for approval in 1960–1961, Kelsey was unconvinced that there was sufficient evidence of the drug’s efficacy and safety. Despite substantial pressure, she held her ground for nineteen months while the extent of the drug’s worldwide damage became known—thousands of stillborn babies, as well as at least 10,000 children across forty-six countries born with severe deformities such as missing limbs, arms, and legs that resembled flippers, and improperly developed eyes, ears, and other organs.
As a result of Kelsey’s efforts, thalidomide was never sold in the United States.
The incident led Congress to pass the 1962 Drug Amendment, which fundamentally changed drug regulation in America. Those regulations, still in force today, required pharmaceutical companies to conduct phased clinical trials, obtain informed consent from participants in drug testing, and warn the FDA of adverse effects, and it granted the FDA important controls over prescription-drug advertising.
One of a small minority of women to earn an advanced degree in science in the 1930s, Kelsey faced challenges that resonate with women scientists to this day.
Revered by the public as a “good mother of science,” she went on to act as a formidable gatekeeper against other suspect drugs, such as diesthylstilbestrol (DES) and laetrile. As part of the team that tested anti-malarial drugs on prisoner volunteers during World War II, she later was instrumental in the formulation of ethical protocols for drug testing on prisoners and the vulnerable, including the elderly and children. Yet behind the public adulation, she faced professional jealousies and glass ceilings, political interference with FDA’s actions, and ongoing hostility from pharmaceutical industry officials. She was sustained and supported by family and friends, co-workers and mentors, and a lifetime commitment to good science.
Based upon FDA archival records, private family papers, and interviews with family and colleagues, this biography highlights the efforts and legacy of a pioneering woman of science whose contributions are still influential today.
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Historia
In the eighteenth century, two men—exact contemporaries and polar opposites—dedicated their lives to the same daunting task: identifying and describing all life on Earth. Carl Linnaeus, a pious Swedish doctor with a huckster’s flair, believed that life belonged in tidy, static categories. Georges-Louis de Buffon, an aristocratic polymath and keeper of France’s royal garden, viewed life as a dynamic swirl of complexities. Each began his task believing it to be difficult but not impossible: How could the planet possibly hold more than a few thousand species—or as many could fit on Noah’s Ark?
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Fascinating history of scientific thought
- De Candy Dan en 06-10-24
De: Jason Roberts
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The Mighty Moo
- The USS Cowpens and Her Epic World War II Journey from Jinx Ship to the Navy's First Carrier into Tokyo Bay
- De: Nathan Canestaro
- Narrado por: Dan Woren
- Duración: 13 h y 29 m
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The USS Cowpens and her crew weren’t your typical heroes. She was a flattop that the US Navy initially didn’t want, with a captain nearly scapegoated for the loss of his last command, pilots who self-trained on the planes they would fly into combat, and sailors that had been in uniform barely longer than the ship had been afloat. Despite their humble origins, Cowpens and her band of second-string reservists and citizen sailors served with distinction, fighting in nearly every major carrier operation from 1943 to 1945, including the Battles of the Philippine Sea and Leyte Gulf.
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Great story
- De greg potts en 07-24-24
De: Nathan Canestaro
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Playing with Reality
- How Games Have Shaped Our World
- De: Kelly Clancy
- Narrado por: Patty Nieman
- Duración: 11 h y 39 m
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Historia
We play games to learn about the world, to understand our minds and the minds of others, and to make predictions about the future. Games are an essential aspect of humanity and a powerful tool for modeling reality. They’re also a lot of fun. But games can be dangerous, especially when we mistake the model worlds of games for reality itself and let gamification co-opt human decision making. Playing with Reality explores the riveting history of games since the Enlightenment.
De: Kelly Clancy
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Night Flyer
- Harriet Tubman and the Faith Dreams of a Free People
- De: Tiya Miles, Henry Louis Gates Jr.
- Narrado por: Janina Edwards
- Duración: 6 h y 5 m
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Harriet Tubman is among the most famous Americans ever born and soon to be the face of the twenty-dollar bill. Yet often she’s a figure more out of myth than history, almost a comic-book superhero. You could almost say she’s America’s Robin Hood, a miraculous vision, often rightly celebrated but seldom understood. Tiya Miles’s extraordinary Night Flyer changes all that.
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academic tripe
- De Amazon Customer en 07-27-24
De: Tiya Miles, y otros
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The Great River
- The Making and Unmaking of the Mississippi
- De: Boyce Upholt
- Narrado por: Gabriel Vaughan
- Duración: 10 h y 18 m
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Over thousands of years, the Mississippi watershed was home to millions of Indigenous people who regarded "the great river" with awe and respect, adorning its banks with astonishing spiritual earthworks. But European settlers and American pioneers had a different vision: the river was a foe to conquer. In this landmark work of natural history, Boyce Upholt tells the epic story of human attempts to own and contain the Mississippi River, from Thomas Jefferson's expansionist land hunger through today's era of environmental concern
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a great summation of the Great River
- De Michael H. Link en 07-27-24
De: Boyce Upholt
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At the Edge of Empire
- A Family's Reckoning with China
- De: Edward Wong
- Narrado por: Edward Wong, Will Dao
- Duración: 16 h y 49 m
- Versión completa
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The son of Chinese immigrants in Washington, DC, Edward Wong grew up among family secrets. His father toiled in Chinese restaurants and rarely spoke of his native land or his years in the People’s Liberation Army under Mao. Yook Kearn Wong came of age during the Japanese occupation in World War II and the Communist revolution, when he fell under the spell of Mao’s promise of a powerful China. His astonishing journey as a soldier took him from Manchuria during the Korean War to Xinjiang on the Central Asian frontier.
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Two tales of change
- De Amanda B. en 07-08-24
De: Edward Wong
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My Black Country
- A Journey Through Country Music's Black Past, Present, and Future
- De: Alice Randall
- Narrado por: Alice Randall
- Duración: 11 h y 10 m
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Alice Randall, award-winning professor, songwriter, and author presents “a celebration of all things country music” (Ken Burns) as she reflects on her search for the first family of Black country music.
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Don’t like country music.
- De Tim en 05-27-24
De: Alice Randall